Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04440371 |
Other study ID # |
21/104/2017 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 21, 2020 |
Est. completion date |
December 30, 2023 |
Study information
Verified date |
September 2022 |
Source |
Jordan University of Science and Technology |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Patients will be included in a randomized controlled clinical trial, will enroll only adult
vitiligo patients with surface area of at least 10% who are being followed in the outpatient
dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on
phototherapy Narrow Band Ultraviolet light B (NBUVB), regardless if they have previous
treatment for their disease, one month wash off period will be given for patients who are
already on phototherapy or other treatments for vitiligo.
Description:
Patients to be included in this randomized controlled study are adults with generalized
vitiligo of surface area of at least 10% who are being followed in the outpatient dermatology
clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy
Narrow Band Ultraviolet light B (NB-UVB), regardless if they have previous treatment for
their disease, one month wash off period will be given for patients who are already on
phototherapy or other treatments for vitiligo. In our going study, adult patients will be
enrolled into 2 groups ( around 20 patients per each) in which NBUVB will be given 2-3
sessions per week in combination with one of the following randomly; one group will start on
Tacrolimus 0.1% ointment twice daily, a second group will start on calcipotriol &
betamethasone containing cream once daily, photos will be taken and the exact sites involved
will be detected, efficacy of treatment will be assessed according to repigmentation
percentages of vitiligo areas from baseline at 3 and 6 months. The improvement at 6 months
compared to baseline will be classified into 5 groups according to the percentage of
repigmentation as follow; excellent (76%-100%); moderate (51%-75%); mild (26%-50%); minimal
(1%-25%); or no response.